Hi Yanin,

The CRF layout is clear and conscience. The appropriate units are provided, and the date and time format are clearly stated. However, I would say it is better to change the time format to 24 hours instead of 12 hours (AM/PM) to reduce human error (for example do not tick the appropriate AM/PM). Another thing that could be improved is the separation of inclusion and exclusion checkbox criteria to help the investigator/interviewer see whether the subject is eligible for the study or not at a glance. One thing missing in the CRF is the Screening ID. Both Screening ID and Subject ID are needed in case we screened participant that is not eligible for enrolment (for example pregnant women).

Your CRF details are really impressive!
I really like the way you design the layout including adding the investigator signature part.

I would say It would be better if you add/adjust some little details in your eCRF
1) Start date: I’m not quite sure that start refers to enrollment or vaccine administration. What do you think if we use “Screening date” instead?
2) Birthday: adding notes like it is Budda era or not, as we conducted a study in Thailand.
3) Subject ID: I wonder that if the subject fails the screening, the subject ID will be left blank right?

Hi Karina and Kansiri,

Thanks to you both for all the comments.

Karina, great suggestion for 24 hours format for time, the checkbox, and screening ID and subject ID. I like and learn a lot from your CRF.

Kansiri,
1) Yes, I agree. Screening date would be more suitable than start date, less confusing.
2) Yes, I saw comments from ajarn that added “25” in the birth year.
3) To be honest, I did not think of the screening ID. My plan was if the subject is not eligible, they would fail to get subject ID and it will be left as a blank. Haha.